Hepatic TransplantationSTEATO-NIRNCT07254533
Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy
A study testing Near-infrared spectrometer in people with Hepatic Transplantation and Steatohepatitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatic Transplantation, Steatohepatitis
- What is being tested?
- Near-infrared spectrometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2027to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver grafts:
- Men or women aged 18 and over
- All donors accepted by the MA4FC procurement team, including brain-dead donors and Maastricht 3 donors, even if placed on a perfusion machine
- Donors whose families have received information about the study and have not expressed any opposition
- Surgical specimens (hepatectomy):
- Men or women aged 18 years and older
Show all 9Show fewer
- Subjects who have undergone surgery for any indication of hepatectomy
- Affiliated with social security,
- Having received information about the study and not having expressed opposition
Who cannot join
- Liver grafts:
- Donors whose liver will be subject to a SPLIT procedure
- Donors for whom there is a medical-legal obstacle
- Donors whose family or loved ones oppose scientific sampling: The hospital coordination team will consult the national refusal register and question loved ones to determine whether the deceased would have opposed sampling. If the donor and/or family oppose scientific sampling, then sampling will not be performed.
- Surgical specimens (hepatectomy):
- Subjects covered by Articles L1121-5 to 1121-8 of the Public Health Code (minors, adults under guardianship or curatorship, patients deprived of their liberty, pregnant or breastfeeding women),
- Subjects who do not understand the French language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Timone Hospital
Marseille, 13005
Sophie Chopinet, 0491435817 ext. +33, promotion.interne@ap-hm.fr
About this study
In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Currently, expanded criteria donors account for 75% of liver transplants, whereas in 2009 they accounted for less than 30% of liver transplants.
Steatosis and its progression Non-alcoholic steatohepatitis (NASH) is an emerging disease in industrialised countries due to obesity, and corresponds to the accumulation of intracytoplasmic triglycerides.
Read more
Steatosis is diagnosed when this fat content represents more than 5% of the total liver mass. There are two types of steatosis: microvesicular steatosis and macrovacuolar steatosis, defined by the presence of lipid droplets larger than the nucleus with a nucleus displaced to the periphery. Macrovacuolar steatosis is responsible for impaired liver function if it is present in ≥30% of hepatocytes. It is a factor in poor prognosis for liver transplants, with reduced graft and recipient survival and an increase in early graft dysfunction after liver transplantation. The quantification of hepatic steatosis is based on the pathological analysis of a liver biopsy, which is currently the gold standard.
This technique has disadvantages: it is an invasive method, requiring an experienced pathologist, and presents inter-individual variability in the assessment and quantification of steatosis.
It is therefore essential to develop new non-invasive diagnostic tools that can identify the presence of steatosis > 5% and ≥ 30%. Several non-invasive techniques for diagnosing steatosis have been studied: Fibroscan, CT scan, MRI, but none of those studied previously allow for the accurate quantification of hepatic steatosis, particularly macrovacuolar steatosis, with instant results.
- Conditions
- Hepatic Transplantation, Steatohepatitis
- Being tested
- Near-infrared spectrometer
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near-infrared spectrometerDevice
Scan of the liver via near-infrared spectrometer
| Study group | Role | What they receive |
|---|---|---|
| liver grafts | Experimental | Not described Receives: Device: Near-infrared spectrometer |
| Surgical specimens (hepatectomy) | Experimental | Not described Receives: Device: Near-infrared spectrometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensibility of near-infrared spectroscopy
Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (>5%).
Measured: through study completion, an average of 1 year
Secondary outcomes (5)
Specificity of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Youden's index of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Likelihood index + and - of the near-infrared spectroscopy
Measured: From enrollment to the end of the study at 12 months
Nanogram likelihood ratio of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
ROC curve of the near-infrared spectroscopy
Measured: From enrollement to the end of the study at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2025
- Study startJan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07254533
- Sponsor's protocol ID
- RCAPHM24_0352
- Other IDs
- 2024-A02004-43
- Acronym
- STEATO-NIR
- Status last verified
- Sep 2026
- First submitted
- 17 Nov 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT07254533
- Acronym / sponsor ID
- STEATO-NIR / RCAPHM24_0352
- Conditions
- Hepatic Transplantation, Steatohepatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Currently, expanded criteria donors account for 75% of liver transplants, whereas in 2009 they accounted for less than 30% of liver transplants.
Steatosis and its progression Non-alcoholic steatohepatitis (NASH) is an emerging disease in industrialised countries due to obesity, and corresponds to the accumulation of intracytoplasmic triglycerides.
Steatosis is diagnosed when this fat content represents more than 5% of the total liver mass. There are two types of steatosis: microvesicular steatosis and macrovacuolar steatosis, defined by the presence of lipid droplets larger than the nucleus with a nucleus displaced to the periphery. Macrovacuolar steatosis is responsible for impaired liver function if it is present in ≥30% of hepatocytes. It is a factor in poor prognosis for liver transplants, with reduced graft and recipient survival and an increase in early graft dysfunction after liver transplantation. The quantification of hepatic steatosis is based on the pathological analysis of a liver biopsy, which is currently the gold standard.
This technique has disadvantages: it is an invasive method, requiring an experienced pathologist, and presents inter-individual variability in the assessment and quantification of steatosis.
It is therefore essential to develop new non-invasive diagnostic tools that can identify the presence of steatosis > 5% and ≥ 30%. Several non-invasive techniques for diagnosing steatosis have been studied: Fibroscan, CT scan, MRI, but none of those studied previously allow for the accurate quantification of hepatic steatosis, particularly macrovacuolar steatosis, with instant results.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| liver grafts | Experimental | Device: Near-infrared spectrometer |
| Surgical specimens (hepatectomy) | Experimental | Device: Near-infrared spectrometer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged 18 and over
- All donors accepted by the MA4FC procurement team, including brain-dead donors and Maastricht 3 donors, even if placed on a perfusion machine
- Donors whose families have received information about the study and have not expressed any opposition
- Men or women aged 18 years and older
- Subjects who have undergone surgery for any indication of hepatectomy
Key exclusion criteria (7 listed)
- Donors whose liver will be subject to a SPLIT procedure
- Donors for whom there is a medical-legal obstacle
- Donors whose family or loved ones oppose scientific sampling: The hospital coordination team will consult the national refusal register and question loved ones to determine whether the deceased would have opposed sampling. If the donor and/or family oppose scientific sampling, then sampling will not be performed.
- Subjects covered by Articles L1121-5 to 1121-8 of the Public Health Code (minors, adults under guardianship or curatorship, patients deprived of their liberty, pregnant or breastfeeding women),
- Subjects who do not understand the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near-infrared spectrometerScan of the liver via near-infrared spectrometer | Device | Surgical specimens (hepatectomy), liver grafts |
Primary outcome
Sensibility of near-infrared spectroscopy
Time frame: through study completion, an average of 1 year
Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (>5%).
5 secondary outcomes
Specificity of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Youden's index of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Likelihood index + and - of the near-infrared spectroscopy
Time frame: From enrollment to the end of the study at 12 months
Nanogram likelihood ratio of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
ROC curve of the near-infrared spectroscopy
Time frame: From enrollement to the end of the study at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Near-infrared spectrometer in people with Hepatic Transplantation and Steatohepatitis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Chopinet, Dr (0491435817 ext. +33, promotion.interne@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensibility of near-infrared spectroscopy (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.